Agency Question: Can you specify the specification for the Viral Harvest Test for ---------------(b)(4)------------------------------------------------------(pg 6 on the draft LRP)?

TWH Response: In Amendment #34, response to Question 9.1 (pg 7 of 9) we indicated that the ----(b)(4)--- specification for pre-filtration Bulk Virus (Viral Harvest) as well as final Formulated Virus would be --------(b)(4)------- In addition, our response under the section, Assay Changes and Updates, 1. --(b)(4)-- (pg 8 of 9), we indicated that the -------(b)(4)------------ method would replace the --------------(b)(4)----- method and be implemented for all Bulk Virus and Formulated Virus. These changes in specification ------(b)(4)------------- and acceptance criteria ----------(b)(4)------ will be implemented with any new batches of Adenovirus Type 4 and Type 7 manufactured by ---(b)(4)-----. However, it must be kept in mind that previously manufactured and released batches of Adenovirus Type 4 and Type 7, either currently in inventory in VA or formulated and currently stored at --(b)(4)--, will have been tested and released using the previous method and acceptance criteria of -----(b)(4)-----. Thus not until newly manufactured batches enter the pipeline will the new specifications be effective.